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November 4, 2022

FDA Expands Vemlidy Use to Adolescents With Chronic HBV FDA Expands Vemlidy Use to Adolescents With Chronic HBV

The US Food and Drug Administration (FDA) has expanded the indication for tenofovir alafenamide (Vemlidy) to children aged 12 years and older with chronic hepatitis B […]
October 25, 2022

FDA OKs Teclistamab for Relapsed/Refractory Multiple Myeloma FDA OKs Teclistamab for Relapsed/Refractory Multiple Myeloma

The US Food and Drug Administration (FDA) has granted accelerated approval to teclistamab (Tecvayli, Janssen Biotech, Inc.) for adults with relapsed or refractory multiple myeloma after […]
October 24, 2022

FDA Approves New Immunotherapy Combo for Liver Cancer FDA Approves New Immunotherapy Combo for Liver Cancer

The US Food and Drug Administration (FDA) has approved a new immunotherapy combination for use in the treatment of unresectable hepatocellular carcinoma (HCC), the most common […]
October 24, 2022

FDA Approves Upadacitinib (Rinvoq) for Sixth Indication FDA Approves Upadacitinib (Rinvoq) for Sixth Indication

The US Food and Drug Administration (FDA) has approved the Janus kinase (JAK) inhibitor upadacitinib (Rinvoq) for adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective […]
October 17, 2022

FDA OKs Medtronic Lead for Left Bundle Branch Pacing FDA OKs Medtronic Lead for Left Bundle Branch Pacing

Labeling for a Medtronic pacing lead, already indicated for stimulation of the His bundle, has been expanded to include the left bundle branch (LBB), the company […]
October 17, 2022

FDA Backs Impella Low Profile Sheath for Use With Heart Pumps FDA Backs Impella Low Profile Sheath for Use With Heart Pumps

The US Food and Drug Administration has granted 510(k) clearance for Abiomed’s Impella Low Profile Sheath used to place and manage Impella heart pumps. “The Low […]
October 12, 2022

FDA Approves Self-administered, SubQ Furosemide Preparation FDA Approves Self-administered, SubQ Furosemide Preparation

The US Food and Drug Administration (FDA) has approved a furosemide preparation (Furoscix, scPharmaceuticals) intended for subcutaneous self-administration by outpatients with chronic heart failure (HF) and […]
October 7, 2022

FDA: Newborns Protected by Whooping Cough Vaccine FDA: Newborns Protected by Whooping Cough Vaccine

The US Food and Drug Administration (FDA) has approved a whooping cough vaccine that protects newborns under 2 months of age. The federal agency on Friday […]
October 4, 2022

EMA Issues Positive Opinion on the Safety of Filgotinib EMA Issues Positive Opinion on the Safety of Filgotinib

The scientific committee of the European Medicines Agency (EMA) has issued a positive opinion of the type II variation application of filgotinib (Jyseleca, Galapagos NV) based […]
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